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Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX

NCT ID: NCT02526550

Last Updated: 2016-12-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2014-07-31

Brief Summary

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This study was undertaken to assess the immunogenicity and safety of a booster dose of a live attenuated chimeric Japanese Encephalitis vaccine (JE-CV) after primary vaccination with SA14-14-2 in Thai children aged 1 to \<5 years. In addition, to assess the impact of the duration interval after primary vaccination on subsequent booster response.

Detailed Description

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The subject will receive one booster dose of IMOJEV with hepatitis A vaccine (inactivated vaccine of GlaxoSmithKline) as concomitant vaccine. Blood samples will be collected to assess for Japanese Encephalitis Neutralizing Antibody at baseline (pre-vaccination) and 4 week post -vaccination.

Conditions

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Encephalitis

Keywords

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Live attenuated Japanese Encephalitis vaccine IMOJEV CD.JEVAX Booster Thai children Immunogenicity Safety Interchangeability Hepatitis A vaccine Vaccination or Other Immunization Procedure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Imojev

Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh

Group Type EXPERIMENTAL

Live attenuated chimeric Japanese Encephalitis vaccine

Intervention Type BIOLOGICAL

0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh

Inactivated Hepatitis A vaccine

Intervention Type BIOLOGICAL

0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh

Interventions

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Live attenuated chimeric Japanese Encephalitis vaccine

0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh

Intervention Type BIOLOGICAL

Inactivated Hepatitis A vaccine

0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh

Intervention Type BIOLOGICAL

Other Intervention Names

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Imojev Havrix

Eligibility Criteria

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Inclusion Criteria

* Children aged 1 to \<5 years on the day of inclusion
* History of received 1 dose of CD.JEVAX at 9-15 months prior to enrollment
* In good general health at the time of inclusion
* Provision of informed consent by the parent(s) or legal guardian(s)

Exclusion Criteria

* Receipt of blood or blood products in the past 3 months
* Acute febrile illness on the day of vaccination (Body Temperature ≥ 38 ◦C)
* Previous receipt of 2 doses of any vaccine against JE virus
* Known hypersensitivity to any of the vaccine components
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
* Planned receipt of any live attenuated vaccine within 4 weeks following the trial vaccination
Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role collaborator

Siriraj Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kulkanya Chokephaibulkit

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kulkanya Chokephaibulkit, Professor

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

References

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Sricharoenchai S, Lapphra K, Chuenkitmongkol S, Phongsamart W, Bouckenooghe A, Wittawatmongkol O, Rungmaitree S, Chokephaibulkit K. Immunogenicity of a Live Attenuated Chimeric Japanese Encephalitis Vaccine as a Booster Dose After Primary Vaccination With Live Attenuated SA14-14-2 Vaccine: A Phase IV Study in Thai Children. Pediatr Infect Dis J. 2017 Feb;36(2):e45-e47. doi: 10.1097/INF.0000000000001395.

Reference Type DERIVED
PMID: 27846060 (View on PubMed)

Other Identifiers

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JEC26-EXT

Identifier Type: -

Identifier Source: org_study_id